Collaboration Details

Title of Collaborative Activity:

Laboratory-Developed Tests (LDT) Interagency Task Force

Description of Collaborative Activity:

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) put together an interagency task force to expand their collaboration around oversight of laboratory-developed tests (LDTs). FDA issued draft guidance in October 2014 for overseeing the quality of LDTs, proposing that the FDA oversee the tests alongside CMS, which regulates labs through the Clinical Laboratory Improvement Amendments (CLIA).